Abbott Biotherapeutics
Corp., Redwood City, CA
Position: Manager, Statistics
(Job code:TB230)
Job
Description: Provide statistical support for clinical programs including
protocol design, SAP development, and clinical trial reporting.
- For protocols, with project team select
appropriate study design, ensure consistency with other protocols,
identify key parameters for sample size, responsible for sample size
estimation, and oversee statistical analysis section.
- Ensure clarity, accuracy and
consistency of CRFs, database definitions, and specifications for analysis
files for individual studies; ensure consistency across studies within a
project.
- Develop SAPs for routine and
non-routine studies.
- Provide input to development of strategy
for data presentation, responsible for statistical and relevant sections
for major deliverables, responsible for accurate interpretation of
analysis results, responsible for high quality deliverables.
- Demonstrates extensive knowledge of
statistical concepts & methodologies related to the pharmaceutical
industry. Demonstrate ability to apply advanced technique to solve
problems, ability to evaluate alternative statistical approaches, to
recommend one with sound reasoning, and to influence non-statistician
colleagues to accept the analytical approach.
- Work collaboratively with
multi-function teams to provide statistical support per timelines. Work
effectively with partners.
- Represent statistics, programming, and
data management in assigned global project team to provide function input
to compound development.
- Be compliant with training
requirements. Effectively mentors less experienced statisticians. As
project lead, coordinates activities of statisticians and programmers, and
reviewing deliverables to ensure quality and speed.
Qualification: MS or Ph.D in (Bio)statistics with a minimum of 6+ years (PhD) or 12+ years (MS) experience
in pharmaceutical industry with solid oncology experience, strong technical skills, and strong
verbal and written communication skills, a thorough knowledge of the drug
development process, experience with submitting and supporting regulatory
agency review of international registration packages and thorough understanding
of ICH Guideline and relevant regulatory requirements, and a good understanding
of SAS and/or SPLUS.
We will also consider
candidates with the following experience;
Principal Research
Statistician: Ph. D. in Statistics with 8-10 years of
pharmaceutical experience, especially in oncology.
Contact: Carrie Dunn, Phone: 847-935-0632 or Email: carrie.dunn@abbott.com
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